Comparing surgery alone to surgery with low-dose radiotherapy for early-stage nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of two surgical approaches for newly diagnosed stage I nasopharyngeal carcinoma. Participants will undergo endoscopic nasopharyngectomy combined with either retropharyngeal lymph node dissection and low-dose radiotherapy or bilateral upper neck lymph node dissection. The study seeks to determine if the surgical approach can achieve similar survival outcomes to conventional radiotherapy while minimizing adverse effects. The trial will include patients with non-keratinized carcinoma who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion Criteria:

* Performance Status Score 0-1 points.
* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
* According to the UICC/AJCC eighth edition staging, the patient is defined as T1N0M0 stage I.
* Adequate organ function: WBC ≥ 4×10\^9 /L, NEUT ≥ 2×10\^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10\^9/L, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.

Exclusion Criteria:

* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
* Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.
* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
* During pregnancy or lactation.
* Other patients that the chief physician considered as illegal for this trial.

Where it's running

• The Fifth Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• The Fifth Affiliated Hospital of Sun Yat-sen University
  Zhuhai, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ming-Yuan Chen, MD,PhD — SUN yet-sen University
• Study coordinator: Ming-Yuan Chen, MD,PhD
• Email: chmingy@email.sysu.edu.cn
• Phone: +8613903052650

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.